Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coronary Artery Disease

Treatments: Procedure: Immediate rotational atherectomy (RA); Procedure: Delayed rotational atherectomy (RA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01701596

RAISE

Details and patient eligibility

About

This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.

Full description

Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Enrollment: 198 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 30 and 85 years old
• nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
• Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria

Exclusion criteria

• acute myocardial infarction
• unprotected left main stenosis
• chronic total occlusion
• saphenous vein graft lesion
• cardiomyopathy
• severe valvular heart disease
• NYHA functional class IV heart failure at baseline
• chronic renal failure on hemodialysis
• severe lung and liver disease or cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Rotational atherectomy (RA)

Experimental group

Description:

Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection

Treatment:

Procedure: Immediate rotational atherectomy (RA)

Delayed rotational atherectomy (RA)

Active Comparator group

Description:

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Treatment:

Procedure: Delayed rotational atherectomy (RA)